Thursday, September 3, 2015 from 3:00 PM to 4:00 PM (PDT)

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Event Details

Vikram Sinha, Ph.D.

Director, Division of Pharmacometrics, Office of Clinical Pharmacology at the U.S. Food and Drug Administration

Update: Dr. Sinha will be joining via conference call.

Drug development and regulatory decisions are driven by information that is compiled primarily from clinical trials and other supportive experiments, but also through clinical experience in the post-market period. The wisdom of these decisions determines the efficiency of drug development, the decision to approve the drug, and the resultant guidance on how to use the product, in the label.

This presentation will address the role and scope of model based drug development throughout the drug development process with a focus on the role its role in regulatory decision making. Challenges faced regarding modeling and simulation in drug development and strategies on the specific use of MBDD in the following areas will be discussed 1) Characterization of dose (exposure) response and dose justification and 3) Rare Diseases.

While the decisions are usually simple in nature (e.g., trial design and project progression at the company, product and labeling approval at FDA), the data informing the decision are complex and diverse. In addition to ensuring quality standards, regulators are looking for evidence regarding appropriate dosing, consistency among multiple end points and evidence that benefits exceed harm.

A reception will take place immediately following the talk in the Rock Hall Atrium.